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Regulatory Activity

 
On April 1, 2008 the FDA announced the establishment of two public dockets: one requesting information and comments on its 2007 Food Protection Plan, the other requesting comments on the use of Third-Party Certification Programs for Foods and Feeds.

The Food Protection Plan is built around three core elements:
 
Prevention
  • Allow FDA to require preventive controls against intentional adulteration by terrorists or criminals at points of high vulnerability in the food chain
  • Authorize FDA to issue additional preventive controls for high-risk foods
  • Require food facilities to renew their FDA registrations every two years and allow FDA to modify the registration categories

Intervention

  • Authorize FDA to accredit highly qualified third parties for voluntary food inspections
  •  Require new re-inspection fee from facilities that fail to meet current Good Manufacturing Practices (cGMPS)
  • Empower FDA to require electronic import certificates for shipments of designated high-risk products
  • Require new Food and Animal Feed Export Certification Fee to improve the ability of U.S. firms to export their products
  • Authorize FDA to refuse admission of imported food if FDA inspection access is delayed, limited or denied

Response

  • Empower FDA to issue a Mandatory Recall if voluntary recalls are not effective
  • Give FDA enhanced access to food records during emergencies
Click here to see United Fresh comments.
 
The FDA final guidance “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” (February 2008) is intended to improve the safety of fresh-cut produce by minimizing the microbial food safety hazards common to all fresh-cut produce processing companies. This guidance is voluntary and does not seek to identify all possible preventive measures to minimize microbial food safety hazards. When used in conjunction with FDA's Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing or holding human food (21 CFR 110) it provides a framework for identifying and implementing appropriate measures to minimize the risk of microbial contamination during the processing of fresh-cut produce.
 
FDA’s draft guidance document “Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods” (February 2008) provides guidance to all FDA-regulated ready-to-eat processed foods industries on how to control Listeria monocytogenes in refrigerated or frozen ready-to-eat foods. United Fresh comments, developed by a working group of the United Fresh Food Safety & Technology Council, emphasized the lack of any epidemiology linking listeriosis to commercially packed or processed fresh produce in over 25 years, and the apparent low incidence of detection of L. monocytogenes in fruits and vegetables at levels likely to cause illness.  United Fresh also noted that the pathogen has never been reported in a significant number of fresh-cut products, even without the extensive ingredient testing and environmental controls recommended in the Guidance.  For additional information about the FDA Guidance or our comments, please contact Dr. David Gombas, senior vice president food safety and technology.
 
In 2004, the U.S. Food and Drug Administration (FDA) released the "Produce Safety From Production to Consumption: Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption."  to address risks throughout a product's life cycle, from the time a food is produced to the time it is distributed and consumed. The plan outlines four major objectives, which include:
  • Preventing contamination of fresh produce by developing guidance and regulations
  • Minimizing the public health impact when contamination of fresh produce occurs
  • Improving communication with the produce industry
  • Facilitating research related to the contamination of fresh produce

The CDC’s mission is to prevent illness, disability and death due to domestic and imported foodborne diseases. An overview of CDC produce food safety activities and programs can be found at http://www.cdc.gov/foodsafety/fsactivities.htm.

Association of Food and Drug Officials (AFDO) is currently leading a workgroup consisting of government, industry, and consumer officials to author a model code for mandatory best practices for produce at the grower and packer level. AFDO believes that food safety at the farm and packinghouse levels are best accomplished through FDA federal regulation in partnership with both USDA/AMS and state regulatory officials.
 
The USDA AMS released an Advance Notice of Proposed Rulemaking (ANPR) on leafy green handling rules, with comments closing on December 3, 2007.  The proposed program would be voluntary, but signatories to the agreement would be required to comply with the agreements regulations, which would specify best practices for minimizing the risk of pathogenic contamination of leafy greens. Click here to see United Fresh comments to USDA on this proposed marketing agreement.

On November 2, 2005, the FDA issued a report titled "Food CGMP Modernization - A Focus on Food Safety” The report recommends revising the existing food CGMP regulations to include new requirements for training, food allergen controls, Listeria monocytogenes controls, temperature controls, written sanitation procedures, and maintenance and inspection of records. The report also recommended that FDA consider applying food CGMPs to establishments engaged in the harvesting, storage, or distribution of raw agricultural commodities and discusses the need for a risk-based approach to food safety regulation. Click here to see United Fresh comments.


United Fresh Produce Association
1901 Pennsylvania Ave. NW
Suite 1100
Washington, DC 20006
Tel: 202 303 3400
Fax: 202 303 3433
united@unitedfresh.org